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Impact of a Probiotic-based Formula on Digestive Symptoms and Mood in Ultra Marathon Runners

NCT06193096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2024-09-19

No results posted yet for this study

Summary

Randomized, prospective, double-blind, placebo-controlled study in ultramarathon runners to evaluate the effects of suplementation with i3.1 probiotic formulation on the relief of common digestive symptoms associated to intense physical exercise. Secondary study outcomes aim to evaluate the effect of the probiotic formulation on fatigue, discomfort and muscle pain, as well as anxiety and mood.

Conditions

  • Signs and Symptoms

Interventions

DIETARY_SUPPLEMENT

Experimental product

Probiotic mix (i3.1) comprising Pediococcus acidilactici KABPTM 021, Lactiplantibacillus plantarum KABPTM 022 and Lactiplantibacillus plantarum KABPTM 023 in a 1:1:1 ratio and with a total concentration of ≥3x10\^9 total colony forming units (CFU) per sachet (stick). Other ingredients are dextrose and maltodextrin as excipients, aroma, flavorings and silicon dioxide. Experimental product will be taken over 4 weeks.

DIETARY_SUPPLEMENT

Control product

Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide. Control product will be taken over to weeks

Sponsors & Collaborators

  • AB Biotics, SA

    lead INDUSTRY

Principal Investigators

  • Salvador Sarrà, PhD · Hospital de Cerdanya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2023-10-10
Completion
2023-10-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193096 on ClinicalTrials.gov